According to a PharmaTimes report, the Psychopharmacologic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has recommended the approval of a single dose of inhaled loxapine (Adasuve™) for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

The 9-8 panel vote was contingent on the company using a risk evaluation and mitigation plan proposed by the FDA which includes screening patients for respiratory risks and monitoring people who take Adasuve for an hour after treatment. The product can cause bronchial spasms that may be fatal in people with conditions such as asthma or chronic obstructive pulmonary disorder.

The FDA is expected to make its final decision by February 4 and Adusave is currently under review in Europe.